Electrical Nerve Stimulation for Nerve Injury

(REGAIN Trial)

Recruiting at 11 trial locations

Overseen By Tracy Cameron, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Epineuron Technologies Inc.

Disqualifiers: Peripheral neuropathy, active implanted device

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 hour

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Temporary Peripheral Nerve Stimulation System, which uses electrical stimulation to aid those with nerve injuries. The goal is to determine if a one-hour session of this treatment is safe and effective. Participants will receive either the actual treatment or a placebo for comparison. Individuals with peripheral nerve injuries (damage to nerves outside the brain and spinal cord) but without neuropathy or implanted devices may qualify. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new treatment options for nerve injuries.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this nerve stimulation system is safe?

Research has shown that temporary peripheral nerve stimulation (PNS) is generally safe and well-tolerated. Various studies have used PNS to help manage pain in different nerve-related conditions. For instance, people with chronic pain reported feeling less pain and experiencing fewer difficulties with daily activities after PNS treatment.

Moreover, the FDA has approved the SPRINT PNS system, similar to the treatment in this trial, for treating certain types of chronic pain. This approval indicates that the system meets safety standards for use in people.

Overall, while each person's experience may vary, previous research supports the safety of temporary PNS in reducing pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Temporary Peripheral Nerve Stimulation System because it offers a unique approach to treating nerve injuries. Unlike standard treatments like pain medications or physical therapy, which often provide only symptomatic relief, this system directly stimulates the nerves. This method may promote nerve regeneration and reduce pain more effectively. Additionally, the system is designed to be temporary and minimally invasive, potentially offering a safer and more convenient option for patients seeking relief from nerve damage without long-term commitment or significant side effects.

What evidence suggests that this nerve stimulation system is effective for nerve injury?

Research has shown that temporary peripheral nerve stimulation (PNS), which participants in this trial may receive, can help reduce pain from nerve injuries. Studies have found that a 60-day PNS treatment can significantly lower pain levels and improve daily functioning. In one trial, half of the participants still felt relief 12 months after treatment. Another study found that PNS can help with various nerve-related pain issues. These findings suggest that this treatment may provide meaningful pain relief for people with nerve injuries. Participants in this trial will receive either the active PNS treatment or a sham treatment for comparison. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals who have recently suffered a peripheral nerve injury. It's not suitable for those with ongoing nerve conditions like peripheral neuropathy or anyone with an active implanted device, such as a pacemaker.

Inclusion Criteria

I have a nerve injury in my arms or legs.

Exclusion Criteria

I do not have numbness, tingling, or pain in my hands or feet.

Patients with any active implanted device

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of electrical stimulation therapy for 1 hour

1 hour

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham Temporary Peripheral Nerve Stimulation System
• Temporary Peripheral Nerve Stimulation System

Trial Overview The study is testing the safety and effectiveness of a new temporary nerve stimulation system that delivers electrical therapy for one hour compared to a sham (inactive) version of the same system.

How Is the Trial Designed?

Group I: Active treatment Experimental Treatment 1 Intervention

Group II: Sham treatment Placebo Group 1 Intervention

Temporary Peripheral Nerve Stimulation System is already approved in United States for the following indications:

Approved in United States as Sprint Peripheral Nerve Stimulation System for:

• Chronic intractable pain of peripheral nerve origin
• Postsurgical and posttraumatic acute pain

Who Is Running the Clinical Trial?

Epineuron Technologies Inc.

Lead Sponsor

Trials

3

Recruited

160+

Published Research Related to This Trial

Temporary electrical stimulation of peripheral nerves and the spinal cord is an effective screening method to identify patients who may benefit from permanent stimulation systems for chronic pain relief.

This technique has shown a high success rate in selecting candidates for permanent implantation, particularly for those suffering from chronic pain due to nerve injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uses of percutaneous electrical stimulation of the nervous system. Long, DM.[2011]

A case study of a 53-year-old woman with chronic lower extremity neuropathic pain showed that a design-specific peripheral nerve stimulation (PNS) device provided significant pain relief and improved functionality for two years after implantation.

This case highlights the effectiveness of modern PNS technology, suggesting it may be a preferable option over spinal cord stimulation for patients with isolated extremity pain, particularly those with spinal abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancement in Neuromodulation Technology with the Innovation of Design-Specific Peripheral Nerve Stimulators: Sural Nerve Stimulation for Radiculopathy. Langford, B., Mauck, WD.[2021]

In a study of patients with chronic neuropathic pain who had previously responded to external noninvasive peripheral nerve stimulation (EN-PNS), all five participants reported continued use of the device and ongoing pain relief after an average of 3.5 years.

Pain intensity significantly decreased from an average of 5.6 to 3.5, and the worst pain reported dropped from 8.6 to 4.8, indicating that EN-PNS can provide long-term benefits for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Treatment of Chronic Neuropathic Pain Using External Noninvasive External Peripheral Nerve Stimulation in Five Patients. Johnson, S., Goebel, A.[2022]

In a case series of 19 patients with non-surgical osteoarthritic knee pain, the use of a temporary peripheral nerve stimulation (PNS) device for 60 days showed significant improvement in knee pain after the device was removed.

The results suggest that temporary PNS could be a promising treatment option for patients with limited therapeutic alternatives, highlighting the need for further high-quality research to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of peripheral nerve stimulation in refractory non-operative chronic knee osteoarthritis. Vangeison, CT., Bintrim, DJ., Helms, J., et al.[2023]

Peripheral nerve stimulation (PNS) is an effective technique for managing various types of chronic and acute pain by using electrical stimulation to inhibit pain signal transmission in both central and peripheral pathways.

PNS works by inhibiting specific pain fibers in the central nervous system and downregulating inflammatory mediators and neurotransmitters involved in pain signaling, making it a versatile option for treating conditions like post-surgical pain, headaches, and phantom limb pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanism of Action of Temporary Peripheral Nerve Stimulation. Abd-Elsayed, A., Attanti, S., Anderson, M., et al.[2023]

In a retrospective study of 46 patients with painful nerve injuries, peripheral nerve stimulation (PNS) provided good pain relief (50% or more reduction) in 78% of cases over a follow-up period of 3 to 16 years.

The average pain intensity significantly decreased from a visual analog scale (VAS) score of 69 before surgery to 24 after PNS, indicating that PNS is an effective long-term treatment option for selected patients with isolated painful neuropathies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term peripheral nerve stimulation for painful nerve injuries. Eisenberg, E., Waisbrod, H., Gerbershagen, HU.[2019]

The distal to proximal neurostimulator lead revision technique is a safe and effective method for adjusting lead positions in patients with chronic pain, as demonstrated in a case series of 3 patients.

All patients experienced over 50% pain reduction at long-term follow-up, indicating that this technique can provide significant relief without the need for replacing the entire neurostimulator system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A technique of distal to proximal revision of peripheral neurostimulator leads: technical note. Mammis, A., Mogilner, AY.[2014]

In a retrospective study of 12 patients with saphenous neuralgia, peripheral nerve stimulation (PNS) showed promising results, with 83% of patients reporting symptom improvement after 6 months, indicating its potential as a non-pharmacologic treatment option.

The average change in pain interference scores at 6 months was 5.8, suggesting a meaningful reduction in pain, although complications were noted in 33% of patients, highlighting the need for careful patient selection and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation for saphenous neuralgia. McCullough, M., Kenney, D., Curtin, C., et al.[2023]

A novel percutaneous peripheral nerve stimulation (PNS) system was evaluated in 24 patients with residual or phantom limb pain after lower-extremity amputation, showing that 75% of participants experienced significant pain relief (≥50%) after up to 60 days of treatment.

The study indicates that percutaneous PNS not only reduces pain but also improves quality of life and function, suggesting it could be a beneficial therapy for Military Service members and Veterans dealing with chronic pain post-amputation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Peripheral Nerve Stimulation for the Treatment of Chronic Pain Following Amputation. Cohen, SP., Gilmore, CA., Rauck, RL., et al.[2022]

External noninvasive peripheral nerve stimulation (EN-PNS) showed significant short-term pain relief in patients with refractory neuropathic pain, with an average reduction of 2.8 points on a numerical rating scale after treatment.

In a study of 20 patients, 40% experienced improvements in quality of life and function, indicating that EN-PNS may be a beneficial option for managing chronic pain, although further controlled studies are needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External Noninvasive Peripheral Nerve Stimulation Treatment of Neuropathic Pain: A Prospective Audit. Johnson, S., Ayling, H., Sharma, M., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37192232/

A Retrospective Review of Real-world Outcomes Following ... This retrospective analysis supports recent prospective studies demonstrating that 60-day percutaneous PNS can provide significant relief across a wide range ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772594423000699

Durable patient-reported outcomes following 60-day ... Treatment of CLBP with 60-day percutaneous PNS treatment produced clinically meaningful improvements in average pain intensity, disability, and/or pain ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10616055/

Temporary Peripheral Nerve Stimulation as Treatment for ... This study demonstrated the potential role for PNS therapy in improving patient-reported pain levels for various neuropathies, targeting various nerves.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07166952

Peripheral Nerve Stimulation With the SPRINT® System in ... This trial demonstrated durable long-term relief at 12-months post-explanation, with 50% of participants having a clinically significant ...

5. tandfonline.com tandfonline.com/doi/full/10.2217/pmt-2022-0005

Real-World Evidence of Sustained Improvement Following ... This study presents real-world data from a cross-sectional follow-up survey of patients who previously received 60-day peripheral nerve stimulation (PNS) ...

6. painphysicianjournal.com painphysicianjournal.com/current/pdf?article=NzY1OQ%3D%3D&journal=152

A Retrospective Review of Real-world Outcomes Following ... Conclusions: This retrospective analysis supports recent prospective studies demonstrating that 60-day percutaneous PNS can provide significant ...